Skip to main content
OpenTrials
Completed

NCT Number: NCT03148210

Undiagnosed COPD and Asthma Population Study (UCAP)

Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed asthma or COPD- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Our study will use targeted casefinding to find people with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their symptoms and their health care use and number of sick days to determine the burden of undiagnosed respiratory disease in these people. The investigators will then determine whether early treatment of previously undiagnosed airflow obstruction will improve patients' health outcomes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases COPD Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects at least 18 years old;
  • Subjects who score > or = to 6 points on The Asthma Screening Questionnaire or > 19.5 points on The COPD Diagnostic Questionnaire;
  • Subjects who have given written informed consent to participate in this trial in accordance with local regulations;
  • Subjects able to perform pre and post bronchodilator spirometry to measure lung function;

Additional Inclusion Criteria for RCT:

Those subjects who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose FEV1 improves by > 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to consent and participate in the RCT.

Exclusion criteria

  • Subjects who report a previous physician diagnosis of asthma.
  • Subjects who report a previous physician diagnosis of COPD
  • Subjects with any of the following conditions within the past 3 months: Heart attack or hospitalization for other heart problems; Stroke; Aortic or cerebral aneurysm; Detached retina or eye surgery
  • Subjects who are in the third trimester of pregnancy
  • Subjects involved in another interventional trial

Treatment and study plan

Treatment strategy using evidence-based guidelines for asthma or COPD

Drug

The respirologist will determine the clinical extent of the patient's symptoms, activity limitation, and degree of airflow obstruction and will commence the subject on asthma or COPD medications if indicated

smoking cessation

Behavioral

Smoking cessation counselling by a qualified educator if currently smoking

Participant Education

Behavioral

Standardized education for asthma or COPD disease

Primary outcomes

  1. Annual rate of patient initiated healthcare utilization events for respiratory illness

    Time frame: 12 months

    Number of visits for respiratory illnesses divided by the length of time in the study

Secondary outcomes

  1. Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.

    Time frame: 12 months

    The change will be expressed as the mean change in the FEV1 measurements at 12 months in comparison to the lung function measurements on the day of randomization.

  2. Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire

    Time frame: 12 months

    The change in general health status will be expressed as the total score of the SF-36 Health Survey Questionnaire at 12 months minus the score on the day of randomization. A total change of 8-10 points in the SF-36 has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate better health status.

  3. Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).

    Time frame: 12 months

    The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 months minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status.

  4. Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)

    Time frame: 12 months

    The change in overall respiratory symptom burden will be expressed as the total score of the COPD Assessment Test at 12 months minus the score on the day of randomization. A total change of - 2 points in the CAT total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate higher burden.

  5. Smoking cessation rate

    Time frame: 12 months

    The number of participants who quit smoking over the 12 month period.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

A Randomized, Controlled, Clinical Trial to Address the Burden of Undiagnosed Airflow Obstruction in Canadian Adults

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
May 10, 2017
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.